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John J Seman began his career in global life science corporations working for E. R. Squibb & Sons and Johnson & Johnson, holding various management positions in sales, marketing and business development. The past 20 years have been spent in entrepreneurial startups where he built an innovative technology based company, Avantec; tripled revenue, and sold a reimbursement services company, HealthBridge, secured initial funding from angel investors for a preclinical research company, PhysioGenix,; founded an innovative dental pain management company, Amorsus Pharma; secured $7.3 million in funding within first 12 months to support entrepreneurial efforts for Launch NY,; and founded an early stage biotech company, ZOETIC Pharmaceuticals, targeting auto immune diseases. Mr. Seman holds a Bachelor of Science degree in Pharmacy, and a Master’s degree, with honors, in Pharmaceutical Economics and Business Administration, from the Massachusetts College of Pharmacy. He is active in industry associations, frequently asked to present at national conferences.
Academic-industry partnering trends reveal a shift in the direction of more openness and cooperation for both academic research institutes and the pharmaceutical industry. Two main factors driving this trend is the emergence of financial pressures on academic institutions and a growing understanding of the increased complexity of developing new innovative therapies.
Julphar, Saudi Arabia
Kishor K Chakraborty is a professional (M Pharm. PhD, MBA) having more than 30 years of diverse global exposure in various research and development assignments with Lederle (a division of American Cyanamid company), Hindustan Antibiotics, Concept Pharma (a farmer subsidiary of Lupin Pharma), Riyadhpharma and currently has been serving as Head – R&D in Julphar Saudi (A leading pharmaceutical company in GCC). He has published & delivered over 20 manuscripts and lectures respectively.
A risk-smart QbD-based methodology driven by improved Informatics goes beyond tactical & reactive development and streamlining standards-based Technology Transfer by capturing mechanistic understanding to support the probabilistic modeling approach from early ideation through research, development, optimization, and scale-up as well as integrating standards (ISA-88 and ISA-95) and structuring data in a fully searchable format. Moreover, the recognition of lean QbD risk assessment through process knowledge is a product lifecycle issue as opposed to a once and done aspect of development is a good first step. That recognition shall catalyze organizational development whose ultimate goal is a broad organizational understanding and competence in QbD concepts and tools, focusing on top-down approach of technology transfer beyond Product Development to include Operations, Engineering, QA, Regulatory Affairs and even Finance. A DIbD (Data-integrating-based-design) supported QbD strategy that expands Research, Development and Manufacturing enables seamless information from across the organization to support continuous product and process improvement. It offers significant opportunities to accelerates products to market, reduces compliance costs and improves product quality by reducing the number of experiment cycles, speeding individual cycles and facilitating technology transfer between cycles. Consistency and standards driven through informatics enable rapid technology transfer between scientists and systems, while Cloud-based software deployments enable remote organizations to collaborate in the QbD process.